Back to resultsSildenafil Citrate in Frozen Embryo Transfer
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil citrate
estradiol valerate
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility focused on measuring IVF
Eligibility Criteria
Inclusion Criteria:
- all cases have at least 2 good quality blastocysts available for transfer
Exclusion Criteria:
- uterine structural abnormalities
- advanced uterine disease
- hydrosalpinx and pyosalpinx
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
estradiol valerate
Sildenafil citrate and estradiol valerate
Arm Description
estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Outcomes
Primary Outcome Measures
endometrial pattern
Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle.
Secondary Outcome Measures
endometrial thickness
Endometrial thickness will be estimated by transvaginal ultrasonography after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate for thickness 8 mm or more every other day from 8th day till 12th day of the menstrual cycle.
biochemical pregnancy test
Serum B,human chorionic gonadotropin subunit will be measured 2 weeks after embryo transfer which will be positive when it's level exceeds 5 milli international unit /milli litre in patient's serum.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02845388
Brief Title
Sildenafil Citrate in Frozen Embryo Transfer
Official Title
Sildenafil Citrate for Endometrial Preparation in Frozen-thawed Embryo Transfer Cycles
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omar Ahmed El Sayed Saad
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
estradiol valerate
Arm Type
Active Comparator
Arm Description
estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Arm Title
Sildenafil citrate and estradiol valerate
Arm Type
Active Comparator
Arm Description
Sildenafil citrate 25 mg every 6 hours orally in combination with estradiol valerate 2mg every 12 hours orally starting from the second day of the menstrual cycle till reaching trilaminar endometrial pattern and endometrial thickness 8 mm or more
Intervention Type
Drug
Intervention Name(s)
Sildenafil citrate
Other Intervention Name(s)
Viagra
Intervention Type
Drug
Intervention Name(s)
estradiol valerate
Primary Outcome Measure Information:
Title
endometrial pattern
Description
Endometrial pattern will be trilaminar or bilaminar after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate. Endometrial pattern will be estimated by transvaginal ultrasonography for trilaminar pattern every other day from 8th day till 12th day of the menstrual cycle.
Time Frame
starting from 8th day till 12th day of the menstrual cycle
Secondary Outcome Measure Information:
Title
endometrial thickness
Description
Endometrial thickness will be estimated by transvaginal ultrasonography after it's preparation with estradiol valerate alone or estradiol valerate and sildenafil citrate for thickness 8 mm or more every other day from 8th day till 12th day of the menstrual cycle.
Time Frame
starting from 8th day till 12th day of menstrual cycle
Title
biochemical pregnancy test
Description
Serum B,human chorionic gonadotropin subunit will be measured 2 weeks after embryo transfer which will be positive when it's level exceeds 5 milli international unit /milli litre in patient's serum.
Time Frame
2 weeks after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all cases have at least 2 good quality blastocysts available for transfer
Exclusion Criteria:
uterine structural abnormalities
advanced uterine disease
hydrosalpinx and pyosalpinx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa mohamed elghannam, professor
Organizational Affiliation
department of obstetric and gynacology Ain shams university
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Sildenafil Citrate in Frozen Embryo Transfer
We'll reach out to this number within 24 hrs